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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005309-35 | EudraCT Number |
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| Name | Class |
|---|---|
| IQVIA Pvt. Ltd | INDUSTRY |
| OCT Clinical Trials | OTHER |
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The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.
This OLE study (CL04041024) included an 82-week open-label Treatment Period that followed completion of one of the core studies (Study CREDO 1, 2 or 3). The OLE open-label Treatment Period lasted from Visit 1 (OLE Baseline/Week 24) to Visit 10 (End of Treatment (EoT)/Week 106), followed by a 20-week Safety Follow-Up Period from Week 106 to Week 126. The first visit of the OLE study was the same visit as the Week 24 visit in the core studies.
Subjects were randomized to 1 of the 2 OKZ treatment groups in the OLE study based on the treatment received in the core studies. Subjects who had received OKZ (q2w or q4w) in the core study in which they had participated (including subjects who received placebo in Study CREDO 3 and were re-randomized to OKZ at Week 16) received the same OKZ treatment regimen in the OLE study. Subjects who had received placebo (Study CREDO 1 and CREDO 2) or adalimumab (Study CREDO 2) in the core study in which they had participated were randomized in a 1:1 ratio to OKZ 64 mg q2w or OKZ 64 mg q4w regimens in the OLE study.
For the first 12 weeks of the OLE, all subjects were required to remain on a stable dose of background methotrexate (MTX) at 15 to 25 mg/week (or≥10 mg/week if there was documented intolerance to higher doses) with a stable route of administration (oral, SC, or intramuscular (IM)). After 12 weeks (Visit 4 [Week 36] of the OLE study), the Investigator might adjust the MTX dosage and route, per local guidelines. Methotrexate might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study.
Subjects who had been on rescue disease-modifying anti-rheumatic drugs (DMARDs) during the core studies were asked to continue these medications for the first 12 weeks of the OLE study. The Investigator could adjust these background medications if deemed appropriate after Visit 4 (Week 36) of the OLE study. Background rescue therapy might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study.
Throughout the study, concomitant treatment with folic acid ≥ 5 mg per week or equivalent was required for all subjects.
Subjects returned to the study site periodically for safety and response assessments as per the Schedule of Events.
The last dose of open-label study treatment in the OLE study was administered at Week 104 for all subjects. After completion of the 82-week open-label Treatment Period, subjects entered the 20-week Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for 3 visits at +4, +8, and +22 weeks after the last dose of study treatment.
Subjects who discontinued the open-label treatment prematurely required to come for the EoT Visit 2 weeks after the last study treatment administration and then return for the 3 Safety Follow-Up Visits +4, +8, and +22 weeks after the last study treatment administration.
Adverse events were assessed throughout the study period and evaluated using the Common Technology Criteria version 4.0 (CTCAE v 4.0).
There were ongoing monitoring of safety events, including laboratory findings by the Sponsor or its designee. In addition, safety parameters were assessed throughout the study by an independent Data Safety Monitoring Board (DSMB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1: OKZ 64 mg q4w + MTX | Experimental | Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). |
|
| Treatment Arm 2: OKZ 64 mg q2w + MTX | Experimental | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olokizumab 64 mg SC q4w | Drug | 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term | up to Week 126 |
| Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population) | Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included. | up to Week 126 |
| Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI) | up to Week 126 | |
| Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment | up to Week 126 | |
| Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure | Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. | up to Week 126 |
| Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure | Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. | up to Week 126 |
| Incidence Rate of Treatment Emergent AESIs (Safety Population) |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82 | Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures:
|
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Inclusion Criteria:
Subjects may be enrolled in the study only if they meet all of the following criteria:
Exclusion Criteria:
Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent Adverse events (AEs) or serious adverse events (SAEs), infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's judgement.
Subject has evidence of active tuberculosis (TB)
Subject with a positive or repeated indeterminate interferon-gamma release assay (IGRA) result at Week 22 of the core study
- Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment:
Subject has planned surgery during the first 12 weeks of the OLE study
Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug
Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment.
Highly effective contraception is defined as:
Female sterilization surgery: hysterectomy, surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first dose of study treatment in the core study
Total abstinence if it is the preferred and constant lifestyle of the subject. Thus, periodic abstinence such as ovulation, symptothermal, postovulation, calendar methods, and withdrawal are not acceptable methods of contraception.
Male sterilization surgery: at least 6 months prior to the first dose of study treatment in the core study (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate). For female subjects, the vasectomized male should be the only partner.
Placement of established intrauterine device (IUD): IUD copper or IUD with progesterone
Barrier method (condom and intravaginal spermicide, cervical caps with spermicide, or diaphragm with spermicide) in combination with the following: established oral, injected, or implanted hormone methods of contraception or contraceptive patch.
Subject is unwilling or unable to follow the procedures outlined in the protocol.
Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of the study treatment, or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible.
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Samsonov | Chief Medical Officer, R-Pharm | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Arthritis & Rheum' Research | Mesa | Arizona | 85210 | United States | ||
| Arizona Arthritis & Rheumatology Associates, P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42142212 | Derived | Fleischmann RM, Strand V, Feist E, Lisitsyna T, Sparks JA, Nasonov E, Samsonov M, Grishin S, Egorova A, Kuzkina S, Smolen JS. Olokizumab Improves Patient-Reported Outcomes in Patients with Active Rheumatoid Arthritis up to 106 Weeks (Results from the Open-Label Extension of Phase III Randomized Clinical Trials). Rheumatol Ther. 2026 May 16. doi: 10.1007/s40744-026-00852-3. Online ahead of print. |
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Enrollment was conducted at 241 sites in 18 countries (Argentina, Belarus, Bulgaria, Brazil, Colombia, Czech Republic, Germany, Estonia, United Kingdom, Hungary, South Korea, Lithuania, Latvia, Mexico, Poland, Russia, Taiwan, United States).
A total of 2105 subjects who had previously completed 24 weeks of double-blind treatment in a core study were randomized. All except one randomized subject received OKZ treatment. A total of 2104 subjects were analyzed for efficacy in the mITT Population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm 1: OKZ 64 mg q4w + MTX | Olokizumab 64 mg subcutaneous (SC) q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2019 |
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| Olokizumab 64 mg SC q2w | Drug | 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
| Concomitant treatment | Drug | Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.) Folic acid ≥ 5 mg per week or equivalent |
|
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. |
| up to Week 126 |
| up to Week 82 |
| American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82 | Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures:
| up to Week 82 |
| American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82 | Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures:
| up to Week 82 |
| Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82 | The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission). The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL) | up to week 82 |
| Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82 | Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) < 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.36 × natural log (CRP+1)] + [0.014 × VAS] + 0.96. | up to Week 82 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 12 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 20 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 28 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 40 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 52 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 64 |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Core baseline, Week 82 |
| Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82 | The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline. HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | up to week 82 |
| Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI) | CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement. The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) | up to week 82 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Arizona Arthritis & Rheumatology Research, PLLC | Sun City | Arizona | 85351 | United States |
| CHI St. Vincent Hot Springs | Hot Springs | Arkansas | 71913 | United States |
| Medvin Clinical Research | Covina | California | 91722 | United States |
| C.V Mehta MD Med Corp.. | Hemet | California | 92543 | United States |
| Advanced Medical Research, LLC | La Palma | California | 90623 | United States |
| Valerius Medical Group | Los Alamitos | California | 90720-5403 | United States |
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
| Rheumatology Center of San Diego | San Diego | California | 92128 | United States |
| East Bay Rheumatology Medical Group, Inc. | San Leandro | California | 94578 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| Center for Rheumatology Research, Comprehensive Rheumatology Center | West Hills | California | 91307 | United States |
| Medvin Clinical Research | Whittier | California | 90602 | United States |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | United States |
| New England Research Associates LLC | Bridgeport | Connecticut | 06606 | United States |
| Javed Rheumatology Associates | Newark | Delaware | 19713 | United States |
| RASF - Clinical Research Center | Boca Raton | Florida | 33486 | United States |
| Reliable Clinical Research, LLC | Hialeah | Florida | 33012 | United States |
| Pharmax Research Clinic | Miami | Florida | 33126 | United States |
| Medical Research Center of Miami | Miami | Florida | 33134 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Omega Research Consultants | Orlando | Florida | 32810 | United States |
| Arthritis Research of Florida, INC | Palm Harbor | Florida | 34684 | United States |
| Family Clinical Trials, LLC. | Pembroke Pines | Florida | 33026 | United States |
| AdventHealth Medical Group, PA | Tampa | Florida | 33614 | United States |
| Lovelace Scientific Resources, Inc. | Venice | Florida | 34292 | United States |
| Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | United States |
| Marietta Rheumatology Associates, PC | Marietta | Georgia | 30060 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| The Arthritis & Diabetes Clinic, Inc. | Monroe | Louisiana | 71203 | United States |
| Klein and Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | United States |
| AA MRC LLC Ahmed Arif Medical Research Center | Grand Blanc | Michigan | 48439 | United States |
| North MS Medical Clinics, Inc. | Tupelo | Mississippi | 38801 | United States |
| Glacier View Research Institute-Rheumatology | Kalispell | Montana | 59901 | United States |
| Physician Research Collaboration | Lincoln | Nebraska | 68516 | United States |
| Arthritis & Osteoporosis Associates, PA | Freehold | New Jersey | 07728 | United States |
| Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | 87114 | United States |
| NYU Langone ambulatory care | Brooklyn | New York | 11201 | United States |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | United States |
| Cape Fear Arthritis Care | Leland | North Carolina | 28451 | United States |
| Carolina Arthritis Associates | Wilmington | North Carolina | 28401 | United States |
| Trinity Medical Group | Minot | North Dakota | 58701 | United States |
| Cincinnati Rheumatic Disease Study Group | Cincinnati | Ohio | 45242 | United States |
| STAT Research, Inc. | Dayton | Ohio | 45417 | United States |
| Clinical Research Source, Inc. | Toledo | Ohio | 43606 | United States |
| Health Research of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73103 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Altoona Center for Clinical Research, P.C. | Duncansville | Pennsylvania | 16635 | United States |
| Arthritis Group | Philadelphia | Pennsylvania | 19152 | United States |
| Low Country Rheumatology, PA | Summerville | South Carolina | 29486 | United States |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | United States |
| Austin Regional Clinic, P.A. | Austin | Texas | 78731 | United States |
| Accurate Clinical Management., LLC | Baytown | Texas | 77521 | United States |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | 76034 | United States |
| Pioneer Research Solutions, Inc. | Cypress | Texas | 77429 | United States |
| Therapeutic Concepts Rheumatology,LLC | Houston | Texas | 77004 | United States |
| Rheumatology Clinic of Houston, P.A. | Houston | Texas | 77065 | United States |
| Houston Institute For Clinical Research | Houston | Texas | 77074 | United States |
| Accurate Clinical Mangemnt - Partner | Houston | Texas | 77089 | United States |
| Accurate Clinical Research, Inc. | Houston | Texas | 77089 | United States |
| Accurate Clinical Research, Inc. | League City | Texas | 77573 | United States |
| West Texas Clinical Research | Lubbock | Texas | 79410 | United States |
| Dr Alex De Jesus Rheumatology, P.A. | San Antonio | Texas | 78229 | United States |
| Advanced Rheumatology of Houston | The Woodlands | Texas | 77382 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Centro de Investigaciones Medicas Mar del Plata | Mar del Plata | Buenos Aires | B7600FYK | Argentina |
| Instituto Medico CER | Quilmes | Buenos Aires | B1878DVB | Argentina |
| Instituto de Investigaciones Clinicas Quilmes | Quilmes | Buenos Aires | B1878GEG | Argentina |
| Sanatorio San Martin | Venado Tuerto | Santa Fe Province | S2600KUE | Argentina |
| Centro Medico Privado de Reumatologia | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Instituto de Investigaciones Clinicas-Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| Organizacion Medica de Investigacion (OMI) | Ciudad Autonoma Buenos Aires | C1015ABO | Argentina |
| APRILLUS Asistencia e Investigacion | Ciudad Autonoma Buenos Aires | C1046AAQ | Argentina |
| Instituto Centenario | Ciudad Autonoma Buenos Aires | C1204AAD | Argentina |
| Hospital Privado Centro Medico de Cordoba | Córdoba | 5016 | Argentina |
| Instituto DAMIC Fundacion Rusculleda | Córdoba | X5003DCE | Argentina |
| CER San Juan Centro Polivalente de Asistencia e Inv. Clinica | San Juan | 5400 | Argentina |
| Centro de Investigaciones Reumatológicas | San Miguel de Tucumán | T4000BRD | Argentina |
| Clinica de Higado y Aparato Digestivo | Santa Fe | S2000CFJ | Argentina |
| Minsk City Clinical Hospital #1 | Minsk | Minsk Oblast | 220013 | Belarus |
| Vitebsk Clinical Hospital | Vitebsk | Vitebsk Oblast | 210037 | Belarus |
| HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza | Ceará | 60430-370 | Brazil |
| CEDOES - Diagnóstico e Pesquisa | Vitória | Espírito Santo | 29055-450 | Brazil |
| CIP - Centro Internacional de Pesquisa | Goiânia | Goiás | 74110-120 | Brazil |
| CMiP - Centro Mineiro de Pesquisa | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| CETI - Centro de Estudos em Terapias Inovadoras Ltda. | Curitiba | Paraná | 80030-110 | Brazil |
| Clinilive - Clínica do Idoso e Pesquisa Clínica | Maringá | Paraná | 87013-250 | Brazil |
| Hospital Bruno Born | Lajeado | Rio Grande do Sul | 95900-010 | Brazil |
| LMK Serviços Médicos S/S Ltda | Pôrto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Clínica de Neoplasias Litoral Ltda. | Itajaí | Santa Catarina | 88301-215 | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-650 | Brazil |
| Centro Multidisciplinar de Estudos Clínicos - CEMEC | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda. | Rio de Janeiro | 20241-180 | Brazil |
| CPCLIN - Centro de Pesquisas Clínicas Ltda. | São Paulo | 01228-200 | Brazil |
| Associação de Assistência à Criança Deficiente - AACD | São Paulo | 04032-060 | Brazil |
| DCC 'Sv. Pantaleymon' OOD | Pleven | 5800 | Bulgaria |
| UMHAT Pulmed OOD | Plovdiv | 4000 | Bulgaria |
| UMHAT "Kaspela", EOOD | Plovdiv | 4001 | Bulgaria |
| MHAT - Ruse, AD | Rousse | 7002 | Bulgaria |
| Medizinski Zentar-1-Sevlievo EOOD | Sevlievo | 5400 | Bulgaria |
| MHAT - Shumen, AD | Shumen | 9700 | Bulgaria |
| NMTH "Tsar Boris III" | Sofia | 1233 | Bulgaria |
| MHAT "Lyulin", EAD | Sofia | 1336 | Bulgaria |
| Medical Center "Excelsior", OOD | Sofia | 1407 | Bulgaria |
| UMHAT "Sv. Ivan Rilski", EAD | Sofia | 1431 | Bulgaria |
| MC "Synexus - Sofia", EOOD | Sofia | 1784 | Bulgaria |
| MDHAT 'Dr. Stefan Cherkezov', AD | Veliko Tarnovo | 5000 | Bulgaria |
| Centro de Reumatologia y Ortopedia SAS | Barranquilla | 80020 | Colombia |
| Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM | Bogotá | 110221 | Colombia |
| Fundacion Instituto de Reumatologia Fernando Chalem | Bogotá | 111211 | Colombia |
| Medicity S.A.S. | Bucaramanga | 680003 | Colombia |
| Clinica de Artritis Temprana S.A.S | Cali | 76001 | Colombia |
| CCR Brno s.r.o | Brno | 602 00 | Czechia |
| IMEDICA s.r.o. | Brno | 602 00 | Czechia |
| Revmatologie s.r.o. | Brno | 638 00 | Czechia |
| Nemocnice Jihlava p.o. | Jihlava | 586 01 | Czechia |
| MUDr Gabriela Simkova Ordinace Lekare Specialisty Interna Revmatologie | Kladno | 272 01 | Czechia |
| CTCenter MaVe s.r.o. | Olomouc | 77900 | Czechia |
| Vesalion s.r.o. | Ostrava | 70200 | Czechia |
| ARTROSCAN s.r.o. | Ostrava - Trebovice | 722 00 | Czechia |
| ARTHROHELP s.r.o. | Pardubice | 530 02 | Czechia |
| CCR Czech, a.s. | Pardubice | 530 02 | Czechia |
| CLINTRIAL s.r.o. | Prague | 110 00 | Czechia |
| Revmatologicky ustav | Prague | 128 00 | Czechia |
| CCR Prague s.r.o. | Prague | 130 00 | Czechia |
| MUDR Zuzana URBANOVA Revmatologie | Prague | 140 00 | Czechia |
| Affidea Praha s.r.o. | Prague | 148 00 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| MUDR Zuzana URBANOVA Revmatologie | Praha 4 Nusle | 140 00 | Czechia |
| Medical Plus s.r.o. | Uherské Hradiště | 686 01 | Czechia |
| PV - MEDICAL, s.r.o. | Zlín | 760 01 | Czechia |
| East Tallinn Central Hospital | Tallinn | 11312 | Estonia |
| Meditrials OU | Tartu | 50708 | Estonia |
| Kerckhoff-Klinik gGmbH | Bad Nauheim | Hesse | 61231 | Germany |
| Rheumapraxis Dr. med. Reiner Kurthen | Aachen | North Rhine-Westphalia | 52064 | Germany |
| Studienambulanz Dr. Wassenberg | Ratingen | North Rhine-Westphalia | 40878 | Germany |
| SMO.MD GmbH | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | 10117 | Germany |
| HRF Hamburger Rheuma Forschungszentrum | Hamburg | 20095 | Germany |
| Principal SMO Kft. | Baja | 6500 | Hungary |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | 8230 | Hungary |
| Clinexpert Kft. | Budapest | 1033 | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | 1036 | Hungary |
| Kiskunhalasi Semmelweis Korhaz | Kiskunhalas | 6400 | Hungary |
| DRC Szekesfehervar | Székesfehérvár | 8000 | Hungary |
| MAV Korhaz es Rendelointezet | Szolnok | 5000 | Hungary |
| Vital-Medicina Kft. | Veszprém | 8200 | Hungary |
| Dr.Saulite-Kandevica Private Practice | Liepāja | LV-3401 | Latvia |
| Alytus Regional S. Kudirkos Hospital, Public Institution | Alytus | 62114 | Lithuania |
| Republican Kaunas Hospital, Public Institution | Kaunas | 45130 | Lithuania |
| Klaipeda University Hospital, Public Institution | Klaipėda | 92288 | Lithuania |
| Siauliai Republican Hospital, Public Institution | Šiauliai | 76231 | Lithuania |
| Center Outpatient Clinic, Public Institution | Vilnius | LT-01117 | Lithuania |
| Vilnius University Hospital Santariskiu Clinics, Public Institution | Vilnius | LT-08661 | Lithuania |
| Clinica de Investigacion en Reumatologia y Obesidad S.C. | Guadalajara | Jalisco | 44650 | Mexico |
| Centro de Estudios de Investigacion Basica y Clinica SC | Guadalajara | Jalisco | 44690 | Mexico |
| Clinicos Asociados BOCM S.C. | Mexico City | Mexico City | 3300 | Mexico |
| Centro de Investigacion Clínica GRAMEL S.C | Mexico City | Mexico City | 3720 | Mexico |
| Comite Mexicano Para la Prevencion de Osteoporosis AC | Mexico City | Mexico City | 6100 | Mexico |
| Clinstile, S.A. de C.V. | Mexico City | Mexico City | 6700 | Mexico |
| Accelerium S. de R.L. de C.V. | Monterrey | Nuevo León | 64000 | Mexico |
| Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Investigacion y Biomedicina de Chihuahua, S.C. | Chihuahua City | 31000 | Mexico |
| Clinical Research Institute S.C. | Mexico City | 54055 | Mexico |
| Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C. | San Luis Potosí City | 78213 | Mexico |
| CERMED | Bialystok | 15-270 | Poland |
| ZDROWIE Osteo-Medic | Bialystok | 15-351 | Poland |
| Szpital Uniwersytecki nr 2 im.dr J. Biziela | Bydgoszcz | 85-168 | Poland |
| MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C. | Grodzisk Mazowiecki | 05-825 | Poland |
| Polimedica Centrum Badań, Profilaktyki I Leczenia | Kielce | 25-355 | Poland |
| CCBR - Lodz - PL | Lodz | 90-368 | Poland |
| Centrum Medyczne AMED | Lodz | 91-363 | Poland |
| ETYKA Osrodek Badan Klinicznych | Olsztyn | 10-117 | Poland |
| Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego | Sieradz | 98-200 | Poland |
| Clinmed Research | Skierniewice | 96-100 | Poland |
| RCMed | Sochaczew | 96-500 | Poland |
| KO-MED Centra Kliniczne Staszow | Staszów | 28-200 | Poland |
| Samodzielny Publiczny ZOZ Tomaszow Lubelski | Tomaszów Lubelski | 22-600 | Poland |
| Nasz lekarz Przychodnie Medyczne | Torun | 87-100 | Poland |
| Medycyna Kliniczna | Warsaw | 00-874 | Poland |
| Rheuma Medicus Zaklad Opieki Zdrowotnej | Warsaw | 02-118 | Poland |
| McM Polimedica | Warsaw | 02-777 | Poland |
| KO-MED Centra Kliniczne Zamosc | Zamość | 22-400 | Poland |
| Santa Familia Centrum Badan, Profilaktyki i Leczenia | Zgierz | 95-100 | Poland |
| FSBEI HE "Altai State Medical University of the Ministry of Healthcare of Russian Federation" | Barnaul | Altayskiy Kray | 656038 | Russia |
| SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans" | Kemerovo | Kemerovo Oblast | 650000 | Russia |
| Medical Center LLC "Maksimum Zdoroviya" | Kemerovo | Kemerovo Oblast | 650066 | Russia |
| Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region | Kursk | Kursk Oblast | 305007 | Russia |
| SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit | Saint Petersburg | Leningradskaya Oblast' | 190068 | Russia |
| SBHI of Moscow "City Clinical Hospital No.1 n.a. Pirogov" Healthcare Department of Moscow | Moscow | Moscovskaya Oblast | 119049 | Russia |
| FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" University Clinical Hospital No.1 | Moscow | Moscovskaya Oblast | 119435 | Russia |
| FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" | Moscow | Moscovskaya Oblast | 119991 | Russia |
| State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department | Moscow | Moscow Oblast | 111539 | Russia |
| SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament" | Moscow | Moscow Oblast | 115093 | Russia |
| SBHI of Nizhegorodsky Region "State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod" | Nizhny Novgorod | Nizhny Novgorod Oblast | 603005 | Russia |
| SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko" | Nizhny Novgorod | Nizhny Novgorod Oblast | 603126 | Russia |
| State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1" | Novosibirsk | Novosibirsk Oblast | 630005 | Russia |
| LLC "Clinical Diagnostic Center "Ultramed" | Omsk | Omsk Oblast | 644024 | Russia |
| Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital" | Omsk | Omsk Oblast | 644111 | Russia |
| SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov" | Petrozavodsk | Republic of Karelia | 185019 | Russia |
| State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov" | Ufa | Respublic of Bashkortostan | 450005 | Russia |
| FSBEI HE "Rostov State Medical Unversity" of Ministry of Health of the Russian Federation | Rostov-on-Don | Rostov Oblast | 344022 | Russia |
| FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov" of the Ministry of Health of Russian Federation | Ryazan | Ryazan Oblast | 390026 | Russia |
| FSBEI HE "Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation" | Saratov | Saratov Oblast | 410012 | Russia |
| State Healthcare Institution "Regional Clinical Hospital" | Saratov | Saratov Oblast | 410053 | Russia |
| Private Healthcare Institution "Clinical Hospital Russian Railways-Medicine of City Smolensk" | Smolensk | Smolensk Oblast | 214025 | Russia |
| FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region "Stavropol Regional Clinical Hospital" | Stavropol | Stavropol Kray | 355030 | Russia |
| State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1" | Yekaterinburg | Sverdlovsk Oblast | 620102 | Russia |
| FSBEI HE "Ural State Medical University" of Ministry of Health of Russian Federation based on MBI "Central City Clinical Hospital No.6" | Yekaterinburg | Sverdlovsk Oblast | 620149 | Russia |
| FSBEI HE "Kazan State Medical University of the Ministry of Health of the Russian Federation" on the base of SAHI "Republican Clinical Hospital of the Ministry of Health of Tatarstan Republic" | Kazan' | The Republic of Tatarstan | 420012 | Russia |
| State Healthcare Institution of Tula region "Tula Regional Clinical Hospital" | Tula | Tulskaya Oblast | 300053 | Russia |
| State Healthcare Institution "Ulyanovsk Regional Clinical Hospital" | Ulyanovsk | Ulyanovsk Oblast | 432063 | Russia |
| SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament | Vladimir | Vladimirskaya Oblast’ | 600023 | Russia |
| SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department | Yaroslavl | Yaroslavl Oblast | 150062 | Russia |
| State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev" | Yaroslavl | Yaroslavsakaya Oblast | 150003 | Russia |
| FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova" | Moscow | 115522 | Russia |
| FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" | Moscow | 119991 | Russia |
| FSBI "National Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation | Saint Petersburg | 197341 | Russia |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 431-796 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 443-380 | South Korea |
| Eulji University Hospital | Daejeon | 35233 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Jeju National University Hospital | Jeju City | 63241 | South Korea |
| Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic | Seoul | 120-752 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 6591 | South Korea |
| Chi Mei Medical Center, Yung Kang Branch | Tainan | 710 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 333 | Taiwan |
| Torbay Hospital | Torquay | Devon | TQ2 7AA | United Kingdom |
| Whipps Cross University Hospital | London | Greater London | E11 1NR | United Kingdom |
| Royal Free Hospital | London | Greater London | NW3 2QG | United Kingdom |
| Basingstoke and North Hampshire Hospital | Basingstoke | Hampshire | RG24 9NA | United Kingdom |
| Maidstone Hospital | Maidstone | Kent | ME16 9QQ | United Kingdom |
| Arrowe Park Hospital | Metropolitan Borough of Wirral | Merseyside | L49 5PE | United Kingdom |
| FG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| mITT |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects who received OKZ in the core study received the same OKZ treatment regimen in the OLE study. Subjects who received in the core study placebo or adalimumab were randomized 1:1 to OKZ 64 mg q2w or OKZ 64 mg q4w regimens in the OLE study. The mITT population included all subjects who signed an ICF for participation in the OLE study, were randomized in the OLE study, received at least 1 dose of study treatment in the OLE study (1057 subjects (OKZ 64 mg q4w), 1047 subjects (OKZ 64 mg q2w)).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm 1: OKZ 64 mg q4w + MTX | Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| BG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) | Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term | Safety Population | Posted | Count of Participants | Participants | up to Week 126 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population) | Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included. | Safety Population | Posted | Count of Participants | Participants | up to Week 126 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI) | Safety Population | Posted | Count of Participants | Participants | up to Week 126 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment | Safety Population (3 Subjects discontinued treatment due to an AE but they did not have an AE that led to treatment discontinuation.) | Posted | Count of Participants | Participants | up to Week 126 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure | Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. | Posted | Number | subjects per 100 subject-years | up to Week 126 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure | Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. | Posted | Number | subjects per 100 subject-years | up to Week 126 |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Incidence Rate of Treatment Emergent AESIs (Safety Population) | Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments. | An AE is defined as treatment-emergent under a given study treatment, if AE's onset date is on or after the date of first dose the corresponding treatment and prior to initiation of the next study treatment, if any. | Posted | Number | subjects per 100 subject-years | up to Week 126 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82 | Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. American College of Rheumatology 20 % response is a composite defined as a ≥ 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥20% improvement from baseline in at least 3 of the 5 remaining core set measures:
| mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Posted | Count of Participants | Participants | up to Week 82 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82 | Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 50 % response is a composite defined as a ≥ 50% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 50% improvement from baseline in at least 3 of the 5 remaining core set measures:
| mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Posted | Count of Participants | Participants | up to Week 82 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82 | Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82 American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% improvement from baseline in at least 3 of the 5 remaining core set measures:
| mITT Population Intermediate missing data are imputed using surrounding visits. Response is calculated relative to the core baseline, the last available assessment prior to the first dose of the study treatment in the core study. | Posted | Count of Participants | Participants | up to Week 82 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82 | The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission). The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL) | Intermediate missing data are imputed using surrounding visits. The Core Baseline value was defined as the baseline value from the core study for subjects that enrol into the OLE study.The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment. | Posted | Count of Participants | Participants | up to week 82 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82 | Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) < 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82. The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.36 × natural log (CRP+1)] + [0.014 × VAS] + 0.96. | Intermediate missing data are imputed using surrounding visits. The Core Baseline value was defined as the baseline value from the core study for subjects that enrol into the OLE study.The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment. | Posted | Count of Participants | Participants | up to Week 82 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 20 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 28 |
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| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 40 |
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| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 52 |
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| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 64 |
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| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82 | HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | mITT Population Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. | Posted | Mean | Standard Deviation | score on a scale | Core baseline, Week 82 |
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| Secondary | Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82 | The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline. HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3, where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. | Intermediate missing data are imputed using surrounding visits. The OLE Baseline value was defined as the last available measurement prior to the first OLE dose of study treatment. | Posted | Count of Participants | Participants | up to week 82 |
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| Secondary | Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI) | CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement. The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) | Subjects with a missing baseline are not included. Intermediate missing data are imputed using surrounding visits. Baseline is defined as the last available assessment prior to the first dose of the study treatment in the core study. | Posted | Mean | Standard Deviation | index units | up to week 82 |
|
Adverse events (AEs) and serious adverse events (SAEs) were reported from OLE Baseline (the same visit as the Week 24 visit in the core studies) until the end of the follow-up period (safety follow-up (SFU-3)). Any AE, including any AE still ongoing at the end of the study, was to be followed until it had resolved, it had a stable sequelae, the Investigator determined that it was no longer clinically significant, or the subject was lost to follow-up.
Safety population consists of all subjects who received at least 1 dose of study treatment during the OLE study CL04041024 . AEs that started before patient enrollment to the OLE study (during core studies CL04041022 (NCT02760368), CL04041023 (NCT02760407) or CL04041025 (NCT02760433) are presented in relevant records for these studies in Clinicaltrials.gov).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm 1: OKZ 64 mg q4w + MTX | Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q4w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. | 13 | 1,043 | 129 | 1,043 | 356 | 1,043 |
| EG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. | 13 | 1,061 | 120 | 1,061 | 386 | 1,061 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bartholinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bullous erysipelas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cat scratch disease | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Encephalomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Joint abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ludwig angina | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Necrotising soft tissue infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Joint ankylosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Traumatic intracranial haematoma | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Supraventricular tachyarrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Salivary gland calculus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Central nervous system neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cervix carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Extranodal marginal zone B-cell lymphoma (MALT type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Lung adenocarcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Marginal zone lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Carotid artery aneurysm | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pineal gland cyst | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperplastic cholecystopathy | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lithiasis | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular stent occlusion | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Splenic cyst | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ocular myasthenia | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Any study related information could be made public available only after Sponsors written permission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sergey Grishin, Head of Scientific Affairs Department | R-Pharm | 0074959567937 | 1506 | sa.grishin@rpharm.ru |
| Mar 23, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592400 | olokizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Other/Mixed |
|
| Argentina |
|
| Hungary |
|
| United States |
|
| Czechia |
|
| United Kingdom |
|
| Belarus |
|
| Russia |
|
| Latvia |
|
| South Korea |
|
| Taiwan |
|
| Brazil |
|
| Poland |
|
| Mexico |
|
| Bulgaria |
|
| Lithuania |
|
| Germany |
|
| Estonia |
|
| Infections and infestations: Upper respiratory tract infection |
|
| Infections and infestations: Bronchitis |
|
| Investigations |
|
| Investigations: Alanine aminotransferase increased |
|
| Investigations: Aspartate aminotransferase increased |
|
| Musculoskeletal and connective tissue disorders |
|
| Blood and lymphatic system disorders |
|
| Blood and lymphatic system disorders: Leukopenia |
|
| Blood and lymphatic system disorders: Neutropenia |
|
| Metabolism and nutrition disorders |
|
| Gastrointestinal disorders |
|
| Injury, poisoning and procedural complications |
|
| Skin and subcutaneous tissue disorders |
|
| Nervous system disorders |
|
| Respiratory, thoracic and mediastinal disorders |
|
| Vascular disorders |
|
| General disorders and administration site conditions |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
|
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
| OG001 | Treatment Arm 2: OKZ 64 mg q2w + MTX | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). Olokizumab 64 mg SC q2w: 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
|
|
|
|